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IRCT20250414065316N1 IRCT 2025-09-23 Shahid Beheshti University of Medical Sciences Oral Health Status and the Impact of an Online Educational Program in People with Multiple Sclerosis Assessment of oral health status and effectiveness of an online oral health promotion program multiple sclerosis patients 2025-12-26 anticipated 201 Complete https://irct.ir/trial/85326 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: To perform randomization, participants were first stratified based on gender (female/male) and age group (18–39 years / 40–60 years) into four distinct strata. Within each stratum, individuals were assigned sequential numerical codes (1, 2, 3, etc.). A random selection of codes was then performed within each stratum using either a table of random numbers or a computer-generated randomization tool. This stratified randomization method helped ensure a balanced distribution of key demographic variables, such as age and gender, across the three intervention groups, thereby enhancing the internal validity of the study, Blinding description: Due to the behavioral and educational nature of the interventions, participant blinding is not feasible, as they will be aware of the type of intervention they receive. However, to minimize bias in outcome assessment, blinding of the outcome assessor and blinding of the clinical supervisor will be implemented. The outcome assessor, responsible for collecting quantitative and qualitative data such as the Plaque Index and Gingival Index, will remain unaware of participants' group allocation to ensure objective and unbiased evaluations. Similarly, the clinical supervisor who monitors participants’ overall health status and manages follow-up will also be blinded to group assignments, reducing potential bias in adverse event reporting and clinical follow-up. Blinding these two roles helps reduce assessment and reporting bias, thereby enhancing the internal validity of the study. N/A Multiple sclerosis. Intervention 1: Intervention group: Oral health education using WhatsApp Delivery method: Online education via the WhatsApp messenger, using text messages, educational images, and short videos. Equipment: Smartphone or tablet with internet access and the WhatsApp application. Number of sessions: 6 educational sessions. Duration of each session: Approximately 15–20 minutes for reading or viewing the content. Total duration: 3 weeks (2 sessions per week).Educational content: Basic oral health concepts (daily oral hygiene, role of nutrition, prevention of dental caries and periodontal diseases).Promoting positive attitudes toward oral hygiene and the importance of regular dental visits. Oral health–related behaviors (proper tooth brushing, flossing, care of prostheses and fillings).Interaction: Weekly Q&A with the researcher, reminders, and motivational messages. Intervention 2: Control group: Participants in this group will not receive any additional educational intervention via messaging platforms or other online methods and will only continue their usual routine care. Yes - There is a plan to make this available What will be shared: Title of the Documents or Data Files: Individual Participant Data from the Clinical Trial on Oral Health Education in Patients with Multiple Sclerosis Details: The collected data include demographic information, Knowledge-Attitude-Practice (KAP) scores regarding oral health, and clinical indicators such as plaque index and periodontal disease index. After de-identification and proper data encryption, partial sharing of the dataset (e.g., primary outcome results) will be possible for research purposes in compliance with ethical standards. When: Timeframe for Data/Document Availability: Data will be available starting 6 months after publication of the final results and will remain accessible to qualified researchers for a period of 3 years. To whom: Authorized Individuals for Access: The data will only be available to academic researchers and individuals affiliated with recognized research institutions. Requests from non-commercial health-related organizations may also be considered. Conditions: De-identified data can only be used for research purposes and statistical analyses related to oral health and the study topic. Commercial or promotional use is not permitted. Applicants must submit a formal request outlining the research aim, type of intended analyses, and approval from an ethics committee or relevant institution. Requests will be reviewed by the research team, and upon approval, limited access will be granted under a data confidentiality agreement. Where to obtain: Applicants wishing to access the data or documents can submit their requests via email to the principal investigator, Dr. Seyed Kian Haji Seyed Javadi, at kian.javadi.dentist@gmail.com. They may also contact by phone at +98 912 641 7256 for further information. For postal correspondence, the research center's address is as follows: Dental Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Shahrak Ghods (West), between Flamark Jonubi and Zarafshan, Simaye Iran Street, Block A, 13th Floo How to obtain: Applicants requesting data or documents must first submit a formal request via email to the principal investigator, including the purpose of use, the type of data or documents needed, and a commitment to comply with the terms of use. Upon receipt, the research team will review the request and, if complete and in accordance with privacy and ethical policies, approve it. Then, a confidentiality agreement outlining usage restrictions will be signed by the applicant. After signing this agreement, the requested data or documents will be provided in an appropriate format, typically within 2 to 4 weeks. If additional information or documents are required, the process may take longer, and the applicant will be informed accordingly. Comments:
public Seyed kian haji seyed javadi
Evin, daneshjooblv, SBMU, dental faculty
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2242 1813 kian.javadi.dentist@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed kian haji seyed javadi
Evin, daneshjoo blv, SBMU
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2242 1813 kian.javadi.dentist@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with a confirmed diagnosis of multiple sclerosis (diagnosis verified through review of the patient’s medical records) Having a minimum of six months since the confirmed diagnosis of multiple sclerosis Patients attending the Omid MS Center in Zanjan who have an active medical file at the center No history of dementia, psychological disorders, or severe physical mobility limitations Ability to read and write (basic literacy) Not completely edentulous (having at least some natural teeth) Possession of a smartphone and the ability to use it 18 years 60 years Both Voluntary withdrawal from the study after enrollment Development of new health conditions or worsening of multiple sclerosis that prevents continued participation Failure to complete more than two educational sessions or follow-up assessments G35 Multiple sclerosis Behavior N/A Intervention group: Oral health education using WhatsApp Delivery method: Online education via the WhatsApp messenger, using text messages, educational images, and short videos. Equipment: Smartphone or tablet with internet access and the WhatsApp application. Number of sessions: 6 educational sessions. Duration of each session: Approximately 15–20 minutes for reading or viewing the content. Total duration: 3 weeks (2 sessions per week).Educational content: Basic oral health concepts (daily oral hygiene, role of nutrition, prevention of dental caries and periodontal diseases).Promoting positive attitudes toward oral hygiene and the importance of regular dental visits. Oral health–related behaviors (proper tooth brushing, flossing, care of prostheses and fillings).Interaction: Weekly Q&A with the researcher, reminders, and motivational messages. Control group: Participants in this group will not receive any additional educational intervention via messaging platforms or other online methods and will only continue their usual routine care. Knowledge of basic concepts of oral health and dentistry. Timepoint: At baseline and three weeks after intervention. Method of measurement: A previously validated questionnaire to assess patients’ knowledge of basic oral health concepts. Attitude toward oral health. Timepoint: At baseline and three weeks after intervention. Method of measurement: A previously validated questionnaire to assess patients’ attitude of basic oral health concepts. Oral health related practice and behavior. Timepoint: At baseline and three weeks after intervention. Method of measurement: A previously validated questionnaire to assess patients’ practice of basic oral health concepts. Plaque index. Timepoint: At baseline and three weeks after intervention. Method of measurement: Clinically assessed using the Silness & Löe Plaque Index (1964), scoring plaque accumulation on four surfaces of each tooth (mesial, distal, buccal, and lingual). Gingival index. Timepoint: At baseline and three weeks after intervention. Method of measurement: Clinically assessed using the Löe & Silness Gingival Index (1963), scoring gingival inflammation and condition on four surfaces of each tooth (mesial, distal, buccal, and lingual). Shahid Beheshti University of Medical Sciences Approved 2025-07-26 Dental Sciences Research Center – Shahid Beheshti University of Medical Sciences Tehran, Shahrak-e Ghods (West), between South Falak and Zarfshan streets, Sima-ye Iran Street – Central Headquarters of the Ministry of Health and Medical Education, Block A, 13th Floor tehran Tehran Iran (Islamic Republic of)